Senior Director, Clinical Operations

Who We Are >>> Why You Should Work With Us

Olema Oncology (OLMA) is a biopharmaceutical company developing innovative targeted therapies for women’s cancers. Our lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN) / selective estrogen receptor degrader (SERD), is in Phase 2 clinical development for the treatment of ER+/HER2- Breast Cancer. Our goal is to transform the standard of care for women living with cancer by developing more convenient and effective therapies.

Onto something bigger, together. Olema is made up of people who are passionate beyond measure. Each and every day, we come together to do amazing things – for each other, for science, and for women with cancer. 

Strategically located in two large biotech hubs – San Francisco, CA and Cambridge, MA – we offer a flexible work environment and the best of both coasts. 

Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses. 

While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities. While at home, employees can make the most of their time – whether that’s picking up the kids from school, going on a mid-day run, or catching up on chores. Through this model, we strive to offer our employees the best of both work models.  

About the Role >>> Senior Director, Clinical Operations

The Senior Director, Clinical Operations, is responsible for leading the overall clinical operations activities for our lead asset compound. An individual in this role will be responsible for leading clinical teams, project and trial planning, budgeting and financial oversight, staff and contract research organization (CRO) management, program/trial clinical operation, timelines and GCP compliance. The ideal candidate is a results-oriented, hands on individual who leads by example.  They will be committed to nurturing a positive and productive work environment for attracting and retaining highly qualified clinical operations professionals.

This is a fantastic opportunity for a talented Clinical Operations leader to join a company with an industry leading Board of Directors and Management team, and roll up their sleeves to build an innovative women’s oncology company with significant potential to transform breast cancer treatments.  

Job Responsibilities:

• Provide direct oversight and management of operations and personnel involved in clinical operations or OP-1250
• Ensure that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices
• Provide operational and clinical expertise and strategic insights to effectively drive the future of OP-1250
• Participate in the review, planning and implementation of clinical trials, including evaluating hypothesis, objectives, study design, feasibility, regulatory requirements, and identifying medical and logistical problems that may impede the study
• Develop clinical timelines and budget forecasts and be accountable for tracking and delivering accordingly
• Provide oversight of global CROs and vendors from identification to selection to close of contracts
• Participate in developing and providing input to protocols, annual safety reports, clinical study reports, publications/presentations and regulatory submissions
• Review master service agreements, statements of work, and quality agreements relating to clinical operations
• Implement best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of SOPs
• Ensure that clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready
• Plan clinical headcount and hiring needs to meet program workload demands. Lead the members of the Clinical Operations team
• Regularly present Clinical Operations updates and strategy to Olema’s executive committee

Job Requirements:

• BS/MS in a scientific discipline or equivalent experience with a minimum of 15 years clinical operations experience in the pharmaceutical/biotech industry, with at least 7 years direct line management experience
• Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and regulatory components is essential. A thorough understanding of drug development from IND to NDA
• Proven success in leading and coordinating cross-functional clinical operations teams. (e.g., clinical operations, data management, clinical supply chain)
• Experience working on complex studies involving biomarkers and activities across multiple vendors
• Knowledge and experience with developing, negotiating and managing contracts (vendor and site)
• Regulatory inspection experience
• Experience in developing RFPs, selection of CROs/vendors, and management of external resources
• Demonstrated ability to manage international clinical trials within designated program budgets and timelines
• Proven success participating in cross-departmental (senior management, regulatory, QA, CMC, program management, finance, business development, medical affairs, clinical development, medical writing) clinical strategy, planning and implementation activities
• Strong working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical operations best practices
• Demonstrated independence, problem-solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment
• Experience with building clinical operations infrastructure including writing of SOPs
• Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing. Experience presenting to the senior leadership team is a plus
• Oncology experience is a plus

The base pay range for this position is expected to be $225,000 - $275,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

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Important Information >>>

We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.

Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. The health and safety of our employees is important to us!

Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

Additional Note/Fraud Alert:  Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.  Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.